morphine sulfate 60 MG Extended Release Oral Tablet
1 INDICATIONS AND USAGE Morphine sulfate extended-release tablets are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Morphine sulfate extended-release tablets are an opioid agonist indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. ( 1 ) Limitations of Use ( 1 ) Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations, reserve morphine sulfate extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. ( 1 ) Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see Warnings and Precautions (5.1) ] , reserve morphine sulfate extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic.
Rhodes Pharmaceuticals L. P.
ROUND ORANGE ABG 60
ABG 60 ROUND ORANGE
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16 HOW SUPPLIED/STORAGE AND HANDLING
MORPHINE SULFATE Extended-Release Tablets are supplied as follows: 15 mg – round, blue-colored, film-coated tablets bearing the symbol ABG on one side and 15 on the other. Bottles (opaque plastic) of 100 tablets NDC 42858-801-01 30 mg – round, Lavender-colored, film-coated tablets bearing the symbol ABG on one side and 30 on the other. Bottles (opaque plastic) of 100 tablets NDC 42858-802-01 60 mg – round, orange-colored, film-coated tablets bearing the symbol ABG on one side and 60 on the other. Bottles (opaque plastic) of 100 tablets NDC 42858-803-01 100 mg – round, gray-colored, film-coated tablets bearing the symbol ABG on one side and 100 on the other. Bottles (opaque plastic) of 100 tablets NDC 42858-804-01 200 mg – capsule-shaped, green-colored, film-coated tablets bearing the symbol ABG on one side and 200 on the other. Bottles (opaque plastic) of 100 tablets NDC 42858-805-01 Store at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store
MORPHINE SULFATE extended-release tablets securely and dispose of properly [see Patient Counseling Information (17) ] . Dispense in a tight, light-resistant container.
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